Records: Different practices across countries?

In some federal states, the question is obviously handled somewhat more generously. According to this, one and the same genetically modified organism (GMO) only needs to be recorded once, even if it is produced x number of times. In contrast, other federal states require that a GMO must always be recorded on Form Z upon production, even if it is produced thousands of times in the same way. The former view, that a one-time inclusion of the GMO in Form Z is sufficient, justifies its opinion by saying that only what can be produced needs to be recorded, not what has actually been produced. Against this background, it is interesting to know whether the question can be clarified using the Genetic Engineering Act (GenTG), the Genetic Engineering Recording Ordinance (GenTAufzV) or Form Z. The Gen TG only rudimentarily regulates the recording obligation in Section 6 Paragraph 3 GenTG. According to this, the operator must keep records and submit them to the competent authority upon request. The Federal Government regulates the details, including the form and content of the records, by statutory order. What exactly needs to be recorded is not specified. Form Z, which is not a mandatory standard form for use in all federal states (see also the AGCT Genetic Engineering report ), is used.  from May 2022 ), nothing explicit emerges in this context. Only from the table, which requires information on when the GMO was produced or received and when the GMO was disposed of, could one conclude that every production/delivery of a GMO must be recorded there. This could also be justified by the fact that records should document the path of a GMO from production to destruction in such a way that the genetic engineering work can be traced even after its completion. The Genetic Engineering Recording Ordinance does not initially provide anything concrete in this regard. According to Section 2 Paragraph 1 No. 7 GenTAufzV, it is only stated that the time of commencement and completion of the genetic engineering work must be recorded. Only if the production of each individual GMO is recorded as a separate genetic engineering work would it follow that each individual production must be recorded. However, Section 2 Paragraph 1 No. 7 GenTAufzV is not that specific. That this view is not mandatory can be deduced from Section 2 Paragraph 3 No. 3 of the GenTAufzV . This Regulation lists specific recording obligations in the production sector. One of these specific obligations is that the number, including the individual production volumes, must be recorded. This, in turn, means that the legislator was already aware of the difference between producing ever new GMOs and repeatedly producing the same GMOs. In the case of GMO production, it therefore only stipulated that the number of batches and the production volumes must be recorded. This, in turn, suggests that even in the laboratory sector, a GMO that is repeatedly produced in the same way only needs to be recorded once. Since the legal basis is not clear in this respect, a permanently coordinated interpretation by the federal states via the Federal/State Working Group on Genetic Engineering (LAG) would be desirable, so that research and production can be carried out under the same conditions nationwide.